An interventional study of Magnetic Flexible Endoscope (MFE) in Colonoscopy, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Device feasibility
In this study, the investigators will evaluate the ability of the Magnetic Flexible Endoscope (MFE) to travel through the human colon. The MFE is a device made of ultra-flexible tubing that contains a camera, light, and magnet at the tip. The tip of the tube is about the size of a penny. The magnet inside the tip allows the MFE to be moved through the colon by a second magnet attached to a robotic arm that is outside the body. The objective of this feasibility study is to determine navigation of the colon and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.
The clinical practice at Vanderbilt University Medical Center (VUMC) is to perform the screening colonoscopic exam while the patient is sedated (Monitored Anesthesia Care administered by the VUMC out-of-OR Anesthesia team) with a legacy colonoscope (Olympus CF/PCF-H190L; Olympus America, Center Valley, PA, USA) to evaluate the patient's colon (via the rectum passed trans-anally with the intent of reaching the cecum). After the screening examination with the legacy colonoscope has been completed and the legacy colonoscope is removed from the patient, the sedation for the patient is stopped as per the standard of care. The patient will be monitored as per VUMC standard of care post-sedation monitoring protocol in the procedure room (post-sedation recovery phase). While the patient is in the post-sedation recovery phase in the procedure room, the MFE will be inserted trans-anally into the rectum and traverse the colon with the intent on reaching the cecum. No additional sedation is administered. After the cecum is visualized, the MFE will be removed from the patient. The patient will continue to be monitored as per VUMC standard of care post-procedure monitoring protocol in the procedure room. Once VUMC standard of care discharge parameters have been met, the patient will be discharged from the procedure area/VUMC as per standard of care. The investigators plan to enroll 5 healthy patients who are already scheduled to undergo their standard of care colonoscopic exam for age-appropriate colorectal cancer screening. The endpoints of the study are navigation of the colon, mucosal visibility, tolerability of the MFE traveling in the human colon, and endoscopist assessment.
Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients in this group will have their colonoscopy for colorectal cancer screening completed with a legacy colonoscope followed by colonoscopy with the Magnetic Flexible Endoscope (MFE).
Device: Magnetic Flexible Endoscope (MFE)
After colonoscopy has been completed with the legacy colonoscope, the MFE will be introduced into the colon and traverse from the rectum to the cecum.
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes
Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes
Time frame: Day 1
MFE Tolerability by Post-procedure Interview
Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure.
Time frame: Day 1
Endoscopist Experience by NASA Task Load Index (TLX)
The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high); the exception is the sub-scale of performance, where 0 is perfect and 100 is failure.
Time frame: Day 1
Colon Mucosal Visibility
Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent.
Time frame: Day 1
| Milestone | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes
| Participants | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes | 0 |
Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure.
| events | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| MFE Tolerability by Post-procedure Interview | 0 |
The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high); the exception is the sub-scale of performance, where 0 is perfect and 100 is failure.
| score on a scale | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Mental | 31 (28 to 33) |
| Physical | 44 (29 to 47) |
| Temporal | 28 (25 to 31) |
| Performance | 47 (46 to 47) |
| Effort | 36 (29 to 45) |
| Frustration | 40 (32 to 45) |
Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent.
| score on a scale | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Colon Mucosal Visibility | 3 (2.8 to 3) |
Collected over Day 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| United States | 5 |
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Vanderbilt University Medical Center